Abstract
Patient experience maps are valuable tools for raising awareness of the patient journey, identifying resource gaps, enhancing access to essential services, and ultimately improving patient outcomes. Here, we describe the development of a metabolic dysfunction–associated steatohepatitis (MASH) patient journey map and its refinement through collaboration with a group comprising eight patient advocates and one person living with MASH, collectively known as the MASH Patient Organizations Who Enable Results (POWER) Council. The patient journey map aimed to identify challenges and unmet needs for people with MASH and to understand the specific experiences of various patient subpopulations. We identified gaps in symptom management, patient–healthcare professional communication, timely diagnoses, access to care, coordination between specialists, and understanding of the impact of MASH on patients’ and caregivers’ daily lives. These gaps were further compounded in those with severe MASH, particularly Hispanic/Latino populations. These findings highlight the challenges and unmet needs faced by people living with MASH and their caregivers.
Introduction
Patients with metabolic dysfunction–associated steatohepatitis (MASH) frequently progress through a clinically silent and heterogeneous disease course, often resulting in delayed identification as well as variable diagnostic and management pathways. This variability is compounded by higher rates of metabolic comorbidities such as obesity, hyperlipidemia, hypertension, type 2 diabetes mellitus, and metabolic syndrome, 1 which can obscure the diagnosis of the underlying MASH. 2
A systematic review and meta-analysis of 368,569 people with MASH found significant racial and ethnic disparities in MASH prevalence and severity, with Hispanic/Latino individuals experiencing the greatest burden. 3 Despite an understanding of the relationship between different genetic dispositions and MASH risk, there are currently no recommendations for the use of genetic testing to identify individuals predisposed to MASH. 3 While liver biopsy has long been considered the reference standard for confirming a MASH diagnosis, it is an invasive procedure with significant limitations, including patient acceptability,4,5 risks of complications, and long waiting times. Recently, non-invasive testing methods that have high diagnostic accuracy for MASH and liver fibrosis without the need for liver biopsy have presented as promising alternative diagnostic tools.6,7
A patient journey map provides a structured approach to characterize key clinical and experiential milestones across the continuum of care, from incidental laboratory abnormalities or imaging findings to fibrosis staging, including non-invasive testing and liver biopsy, and subsequent long-term management.8-10 For hepatology and broader care teams, this framework offers insight into potential gaps in risk stratification, diagnostic sequencing, and patient understanding, while identifying opportunities to improve clinical communication, anticipate patient concerns, and support shared decision-making. Integrating patient-reported experiences with established clinical care pathways may enhance patient-centered care delivery as well as inform more coordinated and effective management strategies for individuals with MASH.
The MASH Patient Organizations Who Enable Results (POWER) Council was convened to understand the current MASH patient journey, identify challenges and areas of unmet need, and understand the specific experiences of subpopulations of people living with MASH. Here, we describe the development of a MASH patient journey map and its refinement by the Council.
Method
Objectives
The objective of this research was to better understand the current MASH patient journey, identify challenges and areas of unmet need, understand the specific experiences of various subpopulations of people living with MASH (eg, those with severe disease, and people of Hispanic/Latino ethnicity), and develop a foundational MASH patient journey map.
Development of the Foundational Patient Journey Map
A North American–focused assessment identified key patient advocacy groups (PAGs) that represent and support the MASH community, and then extracted prioritized elements of the patient journey from PAG resources and channels (Figure 1). Full details on the development of the foundational patient journey map can be found in the Supplemental Materials. Initial research was then conducted to identify available resources, including videos, conferences, abstracts, websites, peer-reviewed publications, white papers, and online forums (Supplemental Table 1 and Supplemental Table 2). Landscape analysis process. Abbreviations: HCP, healthcare professional; MASH, metabolic dysfunction–associated steatohepatitis. aResources included videos, conferences, abstracts, websites, peer-reviewed publications, white papers, and online forums
Resources that were deemed to provide an authentic and accurate perspective of the patient experience were used to develop the foundational MASH patient journey framework. This framework focused on identifying key stakeholders and healthcare professional (HCP) roles, evaluating patient types (eg, those at different stages of disease severity) and subgroups (eg, race and ethnicity), and identifying gaps and opportunities in the care continuum. These key resources were recorded in a database, which included the resource title, source (eg, PAG), type of content (eg, video), and link, as well as the target stakeholder (eg, HCP, patient, caregiver, or advocate), stage of disease, and stage of the patient journey the resource informed on and how.
MASH POWER Council Session
On July 14, 2023, eight patient advocates and one person living with MASH attended the first MASH POWER Council session. Further detail on the composition of the MASH POWER council can be found in the
The primary purpose of the session was to assess, review, and refine the foundational MASH patient journey map (Figure 1). In addition, the Council aimed to identify and understand key challenges/obstacles experienced by people living with MASH across their journey, and the experiences of subpopulations and how these may differ for different subpopulations. The Council also considered the influence of genetic predispositions and the impact this may have on the patient journey and stakeholder roles for patient advocacy. The final MASH patient journey map, from early-stage MASLD to end-stage MASH, was developed based on the research findings and contributions from the Council. The moderator discussion guide can be found in the Supplemental Materials. The session took place virtually and lasted approximately 4 hours. The session was recorded, with the permission of the attendees, and the content was incorporated into the patient journey map.
Results
Foundational Findings: Development of the Foundational Patient Journey Map
A total of 121 pieces of patient content from 30 publicly available sources were evaluated (Supplemental Table 1 and Supplemental Table 2). Themes were identified from the content and used to develop the foundational MASH patient journey map (Supplemental Figure 1).
Assessment and Council-Driven Updates of the Foundational Patient Journey Map
The Council provided suggestions on the foundational patient journey map, which resulted in a comprehensive representation of the MASH patient journey (Figure 2). Quotes collected from Council members on each topic during the session are provided in Supplemental Table 3. Overall, the Council felt that the journey map was reflective of real-world experiences and clearly highlighted the emotional impact of MASH on people living with the disease and caregivers, such as the fear and confusion experienced around diagnosis, disease stages, and treatments. The Council also emphasized the variability and complexity of the patient journey for different people living with MASH. The MASH POWER Council refined patient journey. Abbreviations: ALT, alanine transaminase; AST, aspartate aminotransferase; BMI, body mass index; CT, computed tomography; CVD, cardiovascular disease; FIB-4, fibrosis-4; HCP, healthcare professional; LFT, liver function test; MASLD, metabolic dysfunction–associated steatotic liver disease; MASH, metabolic dysfunction–associated steatohepatitis; MRI, magnetic resonance imaging; NIT, noninvasive test; PCP, primary care physician; POWER, Patient Organizations Who Enable Results. Purple text and purple highlighted boxes denote updates to the patient journey based on the MASH POWER Council meeting. aIf undiagnosed with MASLD, MASH is typically identified during routine screening or the emergence of symptoms post-MASH progression
Challenges in MASH Diagnosis and Treatment That Shaped the Final Patient Journey
Several obstacles (ie, problems, frustrations, or troublesome issues, in this instance experienced by people living with MASH or caregivers) were identified that may provide opportunities to drive change and potentially improve the experience of people living with MASH (Figure 3). The main obstacles are summarized below. Key obstacles in the MASH patient journey. Abbreviations: HCP, healthcare professional; MASH, metabolic dysfunction–associated steatohepatitis; PAG, patient advocacy group
Liver Biopsies
The Council suggested that liver biopsies be deprioritized as the reference standard for MASH diagnosis. A council member noted “Based on recent market research, only 2% of the diagnosed and ICD [International Classification of Diseases]-coded patients in the US undergo liver biopsy,” showing that few patients undergo a liver biopsy outside of a clinical trial setting. This was further strengthened by another quote from a council member: “It’s the rarest thing for anybody out in in the private practice world to go down the biopsy route. You know, I’ve had three biopsies, but it was because I was trying to get in the clinical trials.” The Council also suggested noninvasive testing for all settings outside of a clinical trial; this was incorporated into the patient journey as a clinical cornerstone, and the final journey map was updated to indicate that not all people living with MASH undergo liver biopsy (Figure 2).
Early Screening and Genetic Testing
The Council agreed that early screening efforts and genetic testing may support the identification of high-risk individuals and therefore facilitate early treatment and prevention. The Council acknowledged that individuals may be more receptive to early screening and genetic testing now that approved treatments are available. The final patient journey map was updated to include genetic testing as an option to supplement screening for MASLD and MASH. Information regarding the use of noninvasive imaging or biomarker assessments for early screening and diagnosis as alternatives to liver biopsy was also incorporated (Figure 2).
Multidisciplinary Approach
Traditionally, MASH treatment is overseen by a single HCP specialty focusing on hepatology, endocrinology, or primary care, creating a fragmented care model, particularly for people with comorbidities. “In my experience, once I was referred to a hepatologist, my PCP [primary care physician] played zero role,” a council member stated. A lack of communication and coordination between HCPs can lead to less effective management. A council member stressed the growing need for multidisciplinary care, saying “We have work to do, but that multidisciplinary interdisciplinary care is, I think, really critical.” As MASH symptoms and comorbidities can cover various specialties, a multidisciplinary approach would enable the coordination and sharing of knowledge between the supporting specialists of a person with MASH, which in turn would help combat misinformation and support MASH awareness. The final patient journey map was updated to highlight the need for people living with MASH to be referred to a multidisciplinary team, including dieticians, nutritionists, exercise physiologists, hepatologists, and endocrinologists, to support lifestyle changes and mental health (Figure 2).
Education and Awareness
Poor awareness and education among people living with MASH and HCPs exacerbate missed or late MASH diagnosis, preventing HCPs and people living with MASH from taking early action to initiate treatment. The Council anticipated that, as more effective pharmacotherapy options become available, diagnosis and treatment will increase. The introduction of additional therapies may also result in increased awareness within the patient community and an increase in educated patients driving change through seeking support and treatment. However, an influx of referrals to specialists has the potential to overwhelm the healthcare system and result in longer waiting times. “It will be critically important to meet the needs of patient community and support a collaborative care model that is centered in education, awareness, and treatment options in primary care settings,” stated a council member.
The Council agreed that it is important to engage with HCPs, policymakers, and hospital administrators to address the concerns of people living with MASH and to develop solutions for enhanced healthcare system preparedness. Reinforcing and enhancing relationships with PAGs via advisory boards and patient councils, as well as ongoing efforts to build relationships, will also be fundamental to improving education and awareness of MASH. The Council also emphasized the importance of collaboration and engagement within the medical and patient community in preparation for the increased burden on the healthcare system.
Psychological and Emotional Burden on Patients and Caregivers
The importance of mental health support was highlighted, with the Council explaining that people living with MASH often feel isolated and that their psychological challenges are overlooked. A council member stated “The patient psychologically believes this is an end-stage disease. Whatever future the person thought they had is changed in that moment and they create a new future in their own mind. They go through a process of grieving, much like they do grieving a death.” This illustrates the importance of recognizing the grieving process that many people with MASH and their caregivers experience upon a MASH diagnosis. It is during the diagnostic period that people living with MASH experience the most significant emotional challenges. Support programs for people living with MASH and caregivers, designed in collaboration with mental health professionals, were recommended to provide resources, counseling, and emotional assistance across the entire patient journey and thus alleviate the impact and burden of diagnosis.
Mental health support was noted as an unmet need throughout the various phases of the patient journey, from diagnosis through to ongoing disease management. The added stress and emotional strain faced by caregivers, alongside managing their own health and providing care to family members affected by MASH, was discussed. It was emphasized that MASH should be considered as a ‘family disease’ in which the entire family will often adopt the lifestyle modifications required by the people living with MASH, and that the caregiver also experiences the financial burden related to medical expenses, doctors’ visits, and treatments. “They [my sisters] were very stubborn against having to change anything in their life because they didn’t feel like it. So possibly some mental health things with them would have gone a little further,” a council member stated. As many people living with MASH struggle to achieve lifestyle changes without mental health and behavioral therapy support, the language used in the patient narrative was updated to include this insight (Figure 2).
High-Risk MASH Subpopulations
The Council emphasized that different patient subpopulations, including those at different stages of disease or of different race and ethnicities, drive variation in the patient journey, and several groups are disproportionately affected.
Severity of Disease
People living with MASH advancing to more severe forms of liver disease (eg, fibrosis, cirrhosis, or cancer) may be more willing to participate in clinical trials due to the likelihood that these are their only available treatment options. This may be due to being uninsured or underinsured; however, there are gaps within the guidance and counseling for people living with MASH enrolling in clinical trials, with the Council stressing the importance of compassionate use protocols in clinical trial recruitment. Furthermore, people living with severe MASH and their caregivers experience a greater burden of symptoms and decreased quality of life. Those with atypical or late-stage MASH may also experience heightened frustration that their disease was not identified sooner, increasing distrust and anger in their physician or the healthcare system. “So, I think for a lot of people that think they have this benign, silent, not-even-going-to-bother-me kind of disease, and then all of a sudden it turns into something that’s irreversible,” a council member stated.
Underrepresented Racial and Ethnic Groups
Within underserved communities in North America, particularly those who are Hispanic/Latino, misinformation, systemic racism, and discrimination may lead to distrust of the healthcare system and HCPs. Cultural norms and values within Hispanic/Latino groups may impact people’s willingness to seek diagnostic testing or treatment, and patient risk and experiences can be impacted by cultural stress and their social environment. Individualized approaches to clinical trial design could ensure a patient-driven approach and lessen the distrust experienced by some subpopulations of people living with MASH. There is a need for an inclusive standard of care, independent of insurance status, and it is vital to build trust within communities through transparency and engaging with trusted community members. This was illustrated by a council member: “We were doing a remote look community study screening study in Houston which had a very large Hispanic component and one of the things that was most successful for us was actually working with the Mexican consulate. And the way I interpret that, a trusted third party was affirming that we were good guys.”
Clinical Trials
The Council highlighted challenges and potential solutions with respect to clinical trials (Figure 4). The Council emphasized that it is vital to develop mutually beneficial foundations built upon trust, transparency, and data sharing that give back to the patient community. “This is particularly true for pharmaceutical industry partners who are leading the clinicals but often don’t think of how the community may perceive a clinical trial as a form of healthcare,” stated a council member. Members highlighted that, due to the lack of information provided about what to expect, eg, day-to-day experience, individuals may develop an inaccurate perception of what the trial involves. An outline or testimonial of a person’s experience, supported by a digital app, could be a beneficial method of improving people’s trial expectations and experiences. Findings from the MASH POWER Council meeting around clinical trials. Abbreviations: HCP, healthcare professional; MASH, metabolic dysfunction–associated steatohepatitis; MASLD, metabolic dysfunction–associated steatotic liver disease; POWER, Patient Organizations Who Enables Results
Council members communicated that, once a person is enrolled in a clinical trial, their onsite experience may lack a personal touch, and people may feel they are viewed as a ‘series of tasks’. The person’s experience is also significantly impacted by the facilities and quality of the site, eg, the condition of overnight accommodation. Fundamentally, direct interaction builds a foundation of trust in which patients feel that their needs are understood. Bidirectional strategies to share information with people living with MASH (eg, laboratory values and outcomes) may establish and enhance the value of the clinical trial and strengthen trust in the system for individuals and communities, thereby increasing patient participation.
Discussion
An initial MASH patient journey map was developed based on research findings from publicly available sources. This foundational patient journey map captured the significant challenges faced by people living with MASH through diagnostic aspects and patient narratives related to timely diagnosis, misdiagnosis, misinformation, and insufficient guidance, as well as support around lifestyle changes and lack of emotional and mental support. The MASH POWER Council’s review of this map identified critical gaps in the diagnostic and treatment pathway. These insights stress the importance of a more integrated approach to overcome the challenges associated with MASH diagnosis and treatment.
The Council emphasized the importance of recognizing and addressing psychological challenges, advocating for comprehensive mental health support programs and referrals throughout the disease journey, especially during diagnosis. Lack of mental health support has also been identified in patient journey mapping of other conditions and diseases; a patient journey map developed for cervical dystonia found a lack of clear pathways for referrals to psychologists and psychosocial support. 10 Furthermore, a multidisciplinary care approach, alongside improved education and a more individualized, patient-focused approach to treatment and guidance, must be included in the MASH standard of care.
The Council underscored the disproportionate challenges faced by some racial or ethnic patient populations in accessing diagnosis and treatment. These challenges are exacerbated by political, social, and cultural barriers, along with a lack of education and awareness. The Council emphasized that understanding a community’s requirements through direct interaction and engagement is crucial if trust is to be built between patients and their HCPs. A deeper understanding of the impact of MASH across diverse subpopulations is crucial for designing inclusive and patient-centric clinical trials. Such trials must address the specific needs and challenges of these groups, ensuring that interventions are both effective and equitable. To improve recruitment and retention of patients for clinical trials, the pharmaceutical industry must also work to create stronger trust and better transparency within clinical trial sites. Strategies include publishing complete trial protocols and results, as recommended by CONSORT and SPIRIT guidelines, to enhance credibility. 11 Patient-centric engagement, such as plain-language summaries and continuous communication, has been shown to improve site relationships and retention. 12 The insights into clinical trial development and community engagement will be used to inform discussions in the next MASH POWER Council meeting.
The POWER Council included multiple ethnic backgrounds, including Hispanic and Latino representation, as well as individuals with diverse lived-experience perspectives, caregiving roles, and organizational affiliations. Although one participant was formally included in the analysis as an individual living with MASH, it is important to note that several additional advisory council members representing PAGs also had lived experience with MASH. In total, the council included five individuals with lived experience of MASH, one caregiver, and additional members representing the broader patient community, which both strengthens contextual insight while also highlighting the need for further research with larger, systematically recruited patient cohorts.
The Council’s insights reveal important opportunities to drive progress. Building structured mental health referrals and psychosocial programs into the standard of care offers a pathway to more holistic patient management. Multidisciplinary care models that integrate hepatologists, dietitians, psychologists, and primary care providers can foster individualized treatment approaches. Direct community engagement presents an opportunity to build trust and design culturally sensitive outreach initiatives that address barriers faced by racial and ethnic subpopulations, improving awareness and trial participation. Building trust also requires partnering with individuals and organizations that are already recognized as trusted sources within their communities, including those serving Indigenous populations and other groups with distinct cultural and historical contexts influencing clinical trial participation. Using these insights to advocate for inclusive clinical trial design ensures interventions are representative of the patient population, while transparency measures such as plain-language summaries and continuous communication can strengthen patient–provider relationships and enhance recruitment and retention. Together, these opportunities provide tangible pathways for reshaping the MASH care landscape.
As the primary aim of this study was to develop a foundational, experience-informed representation of the MASH journey, the methods used in this study were intentionally qualitative and focused on synthesizing published evidence with insights from individuals living with or caring for those affected by MASH and related liver conditions. While quantitative triangulation was outside the scope of this initial effort, incorporating such data, particularly metrics on diagnostic timelines, access to specialty care, health disparities, and treatment patterns, would enhance the robustness and generalizability of future iterations of the map.
In the future, the map can be used by clinicians, multidisciplinary care teams, advocacy organizations, and researchers to improve the experience of people living with or at risk of MASH. For clinicians and care teams, the map highlights points along the journey where delayed diagnosis, limited awareness, and inconsistent care pathways commonly occur. These insights can inform actionable steps such as earlier risk stratification, improved communication around disease progression, clearer navigation support, and enhanced integration of lifestyle, behavioral health, and culturally responsive interventions. For advocacy organizations and community partners, the map identifies opportunities to address informational gaps, develop patient education resources tailored to diverse populations, and promote peer and caregiver support models that reflect the lived experience insights shared by our council.
Researchers can apply the map to guide the development of patient-centered outcomes, incorporate lived experience into endpoint selection, and identify barriers to trial participation that may disproportionately affect underrepresented communities. Finally, the patient journey map can support health systems and policy stakeholders by illuminating structural challenges, such as fragmentation of care, limited specialist access, and disparities in diagnosis, that can be targeted for quality improvement initiatives.
Key Insights
This patient journey map identified several key insights across the MASH care continuum, including the substantial mental and emotional burden associated with a largely asymptomatic disease, the invasive and often anxiety-provoking nature of diagnostic procedures such as liver biopsy, and the significant impact of liver disease on the broader family unit. Notably, the findings highlight additional gaps in care among populations at higher risk for disease progression, particularly Hispanic and Latino communities, including systemic challenges in engagement, access to care, and timely diagnosis. The fragmented nature of healthcare delivery further contributes to delays in recognition and inconsistencies in management, underscoring critical opportunities to improve early identification, streamline diagnostic pathways, and implement more culturally responsive, patient-centered approaches to care.
Limitations and Future Directions
This study is not without limitations. Although desktop research and targeted qualitative insights were used to inform the development of the patient journey framework and were subsequently validated through patient advisory council input, the approach may be further strengthened through broader, systematic data collection. In future iterations, incorporating large-scale patient surveys or real-world evidence generated in partnership with patient advocacy organizations could enhance the generalizability, reproducibility, and external validation of the findings.
While the Council had many perspectives from patient advocates, only one person living with MASH had participated in a clinical trial. We recognize that the participants included did not reflect the full breadth of experiences across all people living with MASH. The small sample size of this study limits the generalization of the results. Future iterations should include a larger and more diverse group of people living with MASH, including those representing high-risk groups and underrepresented communities (eg, people from racially, ethnically, and socioeconomically diverse communities, and from regions disproportionately affected by metabolic liver disease). Longitudinal studies and mixed-methods approaches, including quantitative surveys and community-based participatory research, would be beneficial in confirming how the journey map influences outcomes. Additional Council meetings could focus on healthcare system preparedness, liver biopsy utilization, and clinical trial recruitment and retention in more detail. Discussions could expand upon potential methods of collaboration with HCPs to ensure they are adequately prepared to support all aspects of patient care. Further work (eg, pilot implementation) is required to assess the integration of the map into clinical settings and policymaking.
Conclusions
The MASH patient journey is complex, with patients and caregivers facing numerous challenges in diagnosis, treatment, and support, compounded by variations among patient subpopulations. There is a need to increase knowledge and awareness of MASH at both the patient and HCP level to improve patient outcomes. Refinement of the MASH patient journey map by the POWER Council enabled better understanding of MASH, highlighting the challenges and unmet needs faced by patients and their caregivers.
Supplemental Material
Supplemental Material - Development of a Patient Journey Map for Metabolic Dysfunction–Associated Steatohepatitis: A Comprehensive Assessment of the Patient Journey in North America
Supplemental Material for Development of a Patient Journey Map for Metabolic Dysfunction–Associated Steatohepatitis: A Comprehensive Assessment of the Patient Journey in North America by David O. Garcia, Roberto A. Calle, Abhinav Seth, Thomas D. Norton, David J. Lederer, Angela Richardson, Jennifer Berg, Michael Betel, Henry Chang, Heidi Daniels, Wayne Eskridge, Jeff McIntyre, Gina Villiotti Madison, Tony Villiotti and Rosemarie Sellati in Journal of Patient Experience.
Footnotes
Acknowledgements
The authors would like to thank the patient advocacy organizations with whom the MASH POWER Council participants are affiliated who were involved in this research: Fatty Liver Alliance, Fatty Liver Foundation, Liver Education Advocates, Global Liver Institute, United Liver, and American Liver Foundation. Tony Villiotti: you will always be our Rookie of the Year for liver health advocacy - we will miss you, our friend. Medical writing support, under the direction of the authors, was provided by Samantha Cockburn, MSc, of the Prime Group of Companies (Knutsford, UK), funded by Regeneron Pharmaceuticals, Inc., according to Good Publication Practice guidelines (
). The sponsor was involved in the conception and study design, and collection, analysis, and interpretation of data, as well as data checking of information provided in the manuscript. The authors were responsible for all content and editorial decisions, and received no honoraria related to the development of this publication.
Ethical Considerations
This study was noninterventional and intended to obtain insights on the patient’s experience from the patient and stakeholder perspective. Clinical research ethics committee or independent review board approval was not required. Members of the MASH POWER Council were compensated for their time in accordance with fair market value for patient advocates in their respective countries.
Author Contributions
All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis, and interpretation, or in all these areas; took part in drafting, revising, or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.
Funding
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This research was funded by Regeneron Pharmaceuticals, Inc., and supported by IQVIA.
Declaration of Conflicting Interests
The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: David O. Garcia has served as an executive board member for Liver Education Advocates; and has received consulting fees from the MASH POWER Council. Roberto A. Calle, Abhinav Seth, Thomas D. Norton, David J. Lederer, and Rosemarie Sellati are employees of and shareholders in Regeneron Pharmaceuticals, Inc. Angela Richardson and Heidi Daniels have nothing to disclose. Jennifer Berg is a previous shareholder in Madrigal; has received grants/contracts from Madrigal and Regeneron Pharmaceuticals, Inc.; has received payment or honoraria from Madrigal and Regeneron Pharmaceuticals, Inc.; and has received travel expenses and/or support for attendance at meetings from Madrigal and Regeneron Pharmaceuticals, Inc. Michael Betel is President of Fatty Liver Alliance; has participated in a data safety monitoring board/advisory board for Novo Nordisk; has received consultancy fees from Madrigal, Regeneron Pharmaceuticals, Inc., Worldwide Clinical Trials, and PPD; has received payment or honoraria from Sonic Incytes, WebMD, and Medscape Education; has received grants/contracts on behalf of Fatty Liver Alliance from Perspectum, Novo Nordisk, Regeneron Pharmaceuticals, Inc., PPD, Sonic Incytes, Echosens, Inventiva, and Aegle Medical Solutions; and has received support for attendance and travel expenses to meetings from Madrigal, Global NASH Council, and The Liver Forum for Collaborative Research and Predictive Health. Henry Chang has stock options in PharmaNest; has served in a leadership or fiduciary role for PharmaNest, Fatty Liver Foundation, and HIV DART; has received consultancy fees from Madrigal and Regeneron Pharmaceuticals, Inc.; has received payment or honoraria from Icahn School of Medicine at Mount Sinai; and has received support for attendance and travel expenses to meetings from Madrigal. Wayne Eskridge has served as the Chief Executive Officer of the Fatty Liver Foundation; has received support for attendance and travel expenses to meetings from Madrigal; and has received consultancy fees from Madrigal, Novo Nordisk, PathAI, and Regeneron Pharmaceuticals, Inc. Jeff McIntyre is employed by Global Liver Institute which receives membership and grant support, but has no personal disclosures. Gina Villiotti Madison has received grants/funding from Altimmune, Inc., Eisai, Madrigal, Akero, and Regeneron Pharmaceuticals, Inc.; has received support for attendance and travel expenses to meetings from Madrigal; and has received consultancy fees from Madrigal, PPD, and Regeneron Pharmaceuticals, Inc. Tony Villiotti has served as an advisory board member for Liver Education Advocates; has received consultancy fees from Regeneron Pharmaceuticals, Inc., Madrigal, and Eisai; has received travel expenses and support for attendance at meetings from Madrigal; and has received grants/funding on behalf of Liver Education Advocates from Akero, Altimmune, Inc., Eisai, Madrigal, Pfizer, and Regeneron Pharmaceuticals, Inc.
Data Availability Statement
Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, and statistical analysis plan) that support the methods and findings reported in this manuscript. Individual anonymized participant data will be considered for sharing once the product and indication has been approved by major health authorities (eg, FDA, EMA, PMDA, etc.), if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification. Submit requests to .
Supplemental Material
Supplemental material for this article is available online.
References
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